Irritable Bowel Syndrome Digestive System Irritable Bowel Syndrome
Conditions
Interventions
After stratification, participants will be randomised into one of three groups:
1. 3000IU vitamin D spray plus placebo for probiotic (maltodextrin)
2. 3000IU vitamin D spray plus Lab4 probiotic ( 25
Sponsors
University of Sheffield (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-65 years old 2. Diagnosed with IBS 3. Moderate-severe symptom severity
Exclusion criteria
Exclusion criteria: 1. Any antibiotic use in the past 4 weeks (likely to modify gut flora) 2. Any changes in IBS medication/therapies in the last 4 weeks (may affect IBS symptoms which would influence the results of the trial) 3. Pregnant or lactating females 4. Regular use of vitamin/probiotic supplements (again may influence trial results) 5. Any previous GI surgery, GI cancers or inflammatory bowel disease 6. Diabetes mellitus 7. Current use of antidepressants 8. Current or previous use of antipsychotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Total Symptom Severity for IBS, measured by VAS at week 8, and a cumulative measure taken fortnightly across the intervention period (weeks 0, 2, 4, 6 + 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in composite symptom severity, measured by VAS at week 8, and a cumulative measure taken fortnightly across the intervention period (weeks 0, 2, 4, 6 + 8) 2. Change in vitamin D status, measured in serum at baseline and week 8 | — |
Countries
United Kingdom
Outcome results
None listed